On June 18, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapeutics for rare and inflammatory diseases, reported encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway (Press release, Hoth Therapeutics, JUN 18, 2025, View Source;dose-dependent-liver-activity-with-no-observed-toxicity-supports-ind-pathway-302484836.html [SID1234653987]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement.

Key Preclinical Findings (HT-KIT):

Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement.
Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity.
Thymus and other critical organ weights were within normal range across all groups.
No gross pathology or visible lesions observed in any treated animal.
"These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission."

Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after.